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510(k) K193522

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA by Kitazato Corporation — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2020
Date Received
December 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

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